All documents shown here are included in the seminar for instant download

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for
instant download. All reference material as listed below and more is
available on a special seminar website. The website is regularly
updated with most recent information. In case there are questions
related to the topic, they can be submitted through a web form and
will be answered by the speaker. For ordering info
click here.

On-line Audio Seminar 104

FDA's 21 CFR Part 11

Requirements, New Scope and Recommendations
for Implementation

Recorded

In 1997 the United States Food and Drug Administration (FDA) issued a regulation
that provides criteria for acceptance by the FDA of electronic records,
electronic signatures and handwritten signatures. This was done in response to
requests from the industry. With this regulation, entitled Rule 21 CFR Part 11,
electronic records can be equivalent to paper records and handwritten
signatures. The rule applies to all industry segments regulated by the FDA that
includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and
current Good Manufacturing Practice (cGMP).

Questions are:

What are the key requirements?

What are the issues?

What is FDA's new scope and current thinking?

When is electronic audit trail a 'must'?

How to archive records: paper vs. electronic records?

How to deal with legacy systems?

How to develop and implement a gap analysis and remediation
plan?

What is FDA's current thinking and enforcement strategy?

How to document business practices

How to document risk assessment for Part 11

Where to get reference material (gap analysis, examples,
worksheets, SOPs) for easy implementation?

How does the on-line audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new
interactive audio seminar. During the seminar, the speaker will
present strategies and give practical recommendations. After the
seminar, an extensive list of reference material like SOPs, gap
analysis, implementation plan templates and examples will help
immediate and cost effective implementation.

During the interactive presentation you learn:

What are the key requirements?

What are the issues?

What is FDA's new scope and current thinking?

When is electronic audit trail a 'must'?

How to archive records: paper vs. electronic records?

How to deal with legacy systems?

How to develop and implement a gap analysis and remediation
plan?

What is FDA's current thinking and enforcement strategy?

How to document business practices

How to document risk assessment for the FDA?

Where to get reference material (gap analysis, examples,
worksheets, SOPs) for easy implementation?

And for easy and instant implementation:
download 10+ documents from special seminar website

SOP: Define and document scope and controls for part 11

Gap analysis for part 11

SOPs: GxP and part11 training,

Remediation plan and schedule

Paper: 21 CFR Part 11 - Introduction

Paper: New scope of part 11

FDA 483 form inspectional observations and several warning
letters with deviations related to Part 11

About audio seminars

Online audio seminars are presented over the
phone. During the live presentation attendees can:

Study the printed slide material

Watch the slides on a computer

Watch the slides on a video screen in a seminar room

Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
agencies.

Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,
click here.